Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:54 PM
Ignite Modification Date:
2025-12-24 @ 6:54 PM
NCT ID:
NCT06928857
Eligibility Criteria:
Inclusion Criteria:
* 18 years or older
* Diagnosis of first ischemic or hemorrhagic unilateral stroke for at least two weeks
* Medical Research Council score for at least one upper limb muscle greater than 0 and less than 5 (excluding extremes).
* Signed informed consent
Exclusion Criteria:
* Score at the Mini Mental State Examination (adjusted for age and schooling) \< 24
* Clinical evidence in the case of visual disturbance, ideomotor apraxia, behavioral disorders, neglect, sensory, visual and auditory disturbances of severe degree or otherwise that prevent use of the device
* Major head trauma
* Cardio-respiratory or internal clinical instability
* State of pregnancy or lactation
* Severe spasticity (Ashworth \> 3)
* Skin integrity problems at the interface surface with the device
* Implanted electronic devices
* Epilepsy not medically controlled
* Severe peripheral neuropathy
* Recent interventions
* Thrombosis, thrombophlebitis
* Active stent carrier less than six months
* Severe forms of arteriosclerosis, arterial circulatory disorders
* Hypertension not treated
* Cardiac arrhythmias
* Hemorrhagic disorders (hemophilia)
* Severe forms of diabetes mellitus
* Known allergy to materials making up the device or its applied parts
* Cancer or tumour disease
* Acute arthritis
* Other neurological diseases other than stroke
* Progressive muscular dystrophy
* Abdominal or inguinal hernias
* Undiagnosed back pain
* Diseases of internal organs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06928857
Study Brief:
Protocol Section:
NCT06928857